Protocol for the Post-approval Study of Artefill for Correction of Nasolabial Folds

NCT03299712 | Completed

• 1 other identifier: 521-01
• Study Type: interventional
• Target: 1,008
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a five-year, multi-center, non-randomized, non-controlled post-approval study designed to follow a total of 1000 consecutive qualified and consenting subjects treated with ArteFill® in the course of clinical practice at approximately twenty-five centers and all subjects must have a previously documented negative skin test prior to receiving treatment. The incidence of granuloma formation will be monitored.

Conditions

Granulomatous Disorder

Outcome Measures

Primary Outcomes (3)

• The incidence of granuloma formation.

  To determine the incidence of granuloma formation.

  5 years

• Incidence of unanticipated adverse events

  Safety will be assessed based on the incidence of serious unanticipated adverse events. Unanticipated adverse events will be characterized by the severity and relation to the implant product.

  5 years

• Incidence of anticipated adverse events

  The incidence of anticipated adverse events will be assessed at each follow-up visit.

  5 years

Secondary Outcomes (1)

• Assess of subject satisfaction

  5 years

Study Arms (1)

ArteFill

OTHER

This post-approval study will evaluate the continuing safety of ArteFill® as an injectable implant for correction of nasolabial folds over the course of five years post implantation, with a focus on determining the incidence of granuloma formation. Incidence of adverse events and subject satisfaction with respect to the subject's personal expectations will be assessed.

Device: ArteFill

Interventions

ArteFill DEVICE

soft tissue filler

ArteFill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or non-pregnant female 18 years of age or older.
• Subject has provided written and verbal informed consent.
• Subject is willing to comply with study instructions and return to the clinic for required visits.
• Subject is willing to withhold additional aesthetic implant therapies to the NLF \[e.g., other soft tissue fillers: Restylane, Silicone, Radiesse, Sculptra) or implants: gortex, silastic, thread lift, etc.\] for the duration of the study.
• Subject has a documented negative skin test.

You may not qualify if:

• Subject has any skin pathology or condition that could interfere with the evaluation of the treatment areas.
• Subject has a history of systemic granulomatous diseases active or inactive (e.g.
• Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (.e.g., lupus, dermatomyositis, etc.).
• Subject is immuno-compromised in the opinion of the investigator because of disease or medical therapy (e.g., HIV, use of chemotherapy, etc.)
• Subject has been treated with any of the following in their NLF in the time intervals specified prior to the start of their participation in the study:
• Bovine collagen - 6 months
• Porcine or human collagen - one year
• Hyaluronic acid - one year
• Hydroxylapatite - one year
• Autologous fat - at any time
• Polymethylmethacrylate or other acrylates - at any time
• Polyacrylamide - at any time
• Polyethylene oxide - at any time
• Polylactic acid - at any time
• Liquid silicone - at any time

Sponsors & Collaborators

• Suneva Medical, Inc.: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: October 3, 2017
• Study Start: September 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: October 23, 2019

Record last verified: 2019-10